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Reducta - Pharmacare Laboratories Pty Ltd - Complaint No. 2013-02-027

9 May 2014

Update

9 May 2014

On 24 April 2014 PharmaCare Laboratories Pty Ltd provided written assurance to the delegate of the Secretary that they would comply fully with the regulation 9 orders made on 11 April 2014.

Reducta - Pharmacare Laboratories Pty Ltd - Complaint No. 2013-02-027

11 April 2014

Decision under regulation 9 of the Therapeutic Goods Regulations 1990

Pharmacare Laboratories Pty Ltd has been ordered to undertake a number of actions regarding a television advertisement for the product Reducta.

The advertisement was the subject of a complaint to the Complaints Resolution Panel (the Panel) on 27 February 2013 (complaint no. 2013-02-027).

On 8 January 2014, the Panel issued a written determination that the advertisements breached sections of the Therapeutic Goods Advertising Code 2007 (the Code)

On 13 February 2014, as a result of Pharmacare Laboratories Pty Ltd not fully complying with the determination, the Panel recommended the TGA Delegate of the Secretary of the Department of Health (the Delegate) review the matter.

Following investigation, the Delegate's decision was made on 11 April 2014.

The decision

The Delegate found that the advertisement:

  1. contained claims that the advertiser could not demonstrate to be correct, verified and balanced and was therefore in breach of section 4(1)(b) of the Code
  2. was likely to arouse unwarranted and unrealistic expectations of product effectiveness and was therefore in breach of section 4(2)(a) of the Code
  3. was misleading or likely to be misleading and therefore breached section 4(2)(c) of the Code.

The order

The Delegate ordered Pharmacare Laboratories Pty Ltd to:

  1. withdraw any representations, including implied representations, that the product can be used for hunger reduction, unless those representations are worded to the effect that 'Caralluma fimbriata has been traditionally used for hunger reduction in India in times when food was scarce'
  2. not use the representations in (a) above in any other advertisement without the specified 'traditional use' qualification
  3. where the representations have been provided to other parties such as retailers or website publishers, and where there is a reasonable likelihood that the representations have been published or are intended to be published by such parties, to advise those parties that the representations should be withdrawn.

Conditions imposed on the order

Additionally, the Delegate imposed the following conditions under regulation 9(2) in relation to the order:

  1. within 10 working days of being notified of this order, Pharmacare Laboratories Pty Ltd will provide evidence of compliance with this order
  2. within 10 working days of being notified of this order, Pharmacare Laboratories Pty Ltd will provide a written response indicating that Pharmacare Laboratories Pty Ltd will continue to abide by this order.